Surgical clamp having trasmurality assessment capabilities

ABSTRACT

A medical device is provided having a means for actuating a pair of opposing jaw members. The jaw members are movable relative to one another from a first position, wherein the jaw members are disposed in a spaced apart relation relative to one another, to a second position, wherein the jaw members cooperate to grasp tissue therebetween. An ablation mechanism is connected to at least one of the jaws members, such that the jaw members are capable of conducting ablation energy through the tissue grasped therebetween.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of application Ser. No. 10/841,955,filed May 7, 2004, now U.S. Pat. No. 7,819,860, by Dan Wittenberger, etal., entitled SURGICAL CLAMP HAVING TRANSMURALITY ASSESSMENTCAPABILITIES, which application is a continuation-in-part of U.S. patentapplication Ser. No. 10/458,745, filed Jun. 10, 2003, now issued U.S.Pat. No. 7,044,946, the entirety of all of which are incorporated hereinby reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

n/a

FIELD OF THE INVENTION

The present invention relates to a method and system for ablatingtissue, and more particularly to a medical device having a pair ofopposing jaws used for tissue ablation.

BACKGROUND OF THE INVENTION

It is well documented that atrial fibrillation (AF), either alone or asa consequence of other cardiac disease, continues to persist as the mostcommon type of cardiac arrhythmia. In the United States, AF currentlyaffects an estimated two million people, with approximately 160,000 newcases being diagnosed each year. The cost of treatment for AF alone isestimated to be in excess of $400 million worldwide each year.

Although pharmacological treatment is available for AF, the treatment isfar from perfect. For example, certain antiarrhythmic drugs, likequinidine and procainamide, can reduce both the incidence and theduration of AF episodes. Yet, these drugs often fail to maintain sinusrhythm in the patient. Cardioactive drugs, like digitalis, Betablockers, and calcium channel blockers, can also be given to control AFby restoring the heart's natural rhythm and limiting the naturalclotting mechanism of the blood. However, antiarrhythmic drug therapyoften becomes less effective over time. In addition, antiarrhythmic drugcan have severe side effects, including pulmonary fibrosis and impairedliver function.

Another therapy for AF is surgery. In a technique known as the “Maze”procedure, a surgeon makes several incisions through the wall of theatrium with a scalpel and then sews the cuts back together, creating ascar pattern. The scars isolate and contain the chaotic electricalimpulses to control and channel the electrical signals. The Mazeprocedure is expensive, complicated to perform, and associated with longhospital stays and high morbidity.

An alternative to open heart or open chest surgery is a minimallyinvasive treatment in which ablation devices are used to form scars invarious locations in the atrial tissue. Ablation devices that apply heator cold to body tissue are known. Typically, these devices have anelongate, highly-flexible shaft with a steerable distal end fornegotiating a path through the body of a patient. Rigid shaft devicesare used in more invasive procedures where a more local opening ordirect access to a treatment site is available or created.

It is important to note that these devices are used in an attempt toablate tissue through the full thickness of the cardiac wall, and thuscreate a risk associated with damaging structures within or on the outersurface of the cardiac wall. Accordingly ablation devices have beendeveloped which include opposing jaw members to ablate tissue from bothsides of the cardiac wall. For example, U.S. Pat. No. 6,161,543 to Cox;U.S. Pat. No. 5,733,280 to Avitall; and U.S. Pat. No. 6,517,536 toHooven describe techniques for ablating tissue of organs or vesselshaving opposing walls and disclose ablation devices having clampingmembers to clamp a treatment site therebetween. Such devices includerigid members/shafts to facilitate reaching the tissue treatment site.

While rigid shafts may be useful in some applications, they have certainlimitations as well. For example, without a preset shape for reaching aparticular location in the body of a patient, the rigid nature of theshaft limits the area of tissue that can be reached and treated. Evenwhere a relatively large incision is provided, tissue areas that are notat least somewhat directly accessible cannot be reached.

Although a rigid shaft can be provided with a predetermined shape, onemust select a device with a rigid shaft that has the most appropriateshape for positioning the working portion of the device in contact withthe treatment site in view of the particular anatomical pathway to befollowed in the patient. It will be appreciated that a large inventoryof devices having rigid shafts may be required to accommodate thevarious treatment sites and patient anatomies. As an example, U.S. Pat.No. 6,161,543 to Cox el al. describes a variety of rigid probe shapes.Further, for a patient having a relatively uncommon anatomicconfiguration and/or a difficult to reach treatment site, all rigiddevices of an existing set may have less than optimal shapes forpositioning. This may impair the prospects of successfully carrying outthe treatment procedure. For an ablation device which must bear againsttissue at the remote region to create lesions, the contour followed bythe device in reaching the target site will in general further restrictthe direction and magnitude of the movement and forces which may beapplied or exerted on the working portion of the device to effect tissuecontact and treatment.

SUMMARY OF THE INVENTION

The present invention advantageously provides a surgical clamp having apair of opposing jaw members that are movable relative to one anotherfrom a first position, wherein the jaw members are disposed in a spacedapart relation relative to one another, to a second position, whereinthe jaw members cooperate to grasp tissue therebetween. An ablation toolis connected to at least one of the jaws members, such that the jawmembers are capable of conducting ablation energy through the tissuegrasped therebetween.

In an exemplary embodiment, a medical device for ablating tissue isprovided, having a pair of opposing jaws positionable from a firstposition to a second position, at least one of the opposing jawsincluding an ablation element, and a shaft assembly operable connectedto the opposing jaws. The shaft assembly has a malleability such thatthe shaft assembly retains a first shape until manipulated to a secondshape.

In another embodiment, a medical device for ablating tissue is provided,including a first jaw and a second jaw, where the first jaw includes afirst jaw ablation tool having at least one first jaw ablation segment.A shaft assembly is also provided. The shaft assembly is operablyconnected to the first jaw and the second jaw, and is malleable suchthat the shaft assembly retains a first shape until manipulated to asecond shape. The medical device also includes a handle assembly that isattached to the shaft assembly opposite the first jaw and the secondjaw. The handle assembly is operably connected to the first jaw and thesecond jaw to move the first jaw and the second jaw from a firstposition to a second position.

In yet another exemplary embodiment, a medical device for ablatingtissue is provided having a first jaw and a second jaw, the first jawincluding a first jaw ablation tool configured to circulate cryogenicfluid therethrough and having at least one first jaw ablation segment.Also included is a shaft assembly operably connected to the first jawand the second jaw. The shaft assembly has malleability such that theshaft assembly retains a first shape until manipulated to a secondshape. The medical device further includes a handle assembly attached tothe shaft assembly opposite the first jaw and the second jaw, where thehandle assembly is operably connected to the first jaw and the secondjaw to move the first jaw and the second jaw from a first position to asecond position. An ablation control system is operably connected to thefirst ablation tool.

In another exemplary embodiment, a medical device is provided having anelongated shaft, a cooling element, and a second element movable withrespect to the cooling element to define a clamp, wherein the movableelement is selectively detachable from the shaft.

In an exemplary method, a method of ablating tissue includes the stepsof: providing an ablating device having a pair of opposing jawspositionable from a first position to a second position, where at leastone of said opposing jaws includes an ablation tool and a shaft assemblyoperable connected to the opposing jaws, the shaft assembly having amalleability such that the shaft assembly retains a first shape untilmanipulated to a second shape; manipulating the shaft assembly from thefirst shape to the second shape; positioning the opposing jaws in thefirst position such that the opposing jaws are in a spaced apartrelation; placing the opposing jaws about the tissue to be treated;positioning the opposing jaws in the second position such that theopposing jaws grasp the tissue to be treated; and ablating the tissue tobe treated.

In another exemplary method, a method for evaluating transmurality of alesion is provided and includes the steps of positioning a first and asecond jaw of an ablating device about tissue to be treated; applying acooling element to at least the first jaw of the ablating element; andmeasuring temperature from a temperature sensor associated with thesecond jaw of the ablating device.

In another exemplary embodiment, a medical device for evaluatingtransmurality of a lesion is provided including a shaft assembly havingmalleability such that the shaft assembly retains a first shape untilmanipulated to a second shape, a proximal jaw, operably connected to theshaft assembly, a pair of sensors extending from the proximal jaw, and ahandle assembly attached to the shaft assembly opposite the proximaljaw, the handle assembly being operably connected to the proximal jaw tomove the pair of sensors from a first position to a second positionproximate an ablation site.

In another exemplary embodiment, a medical device having ablation andtransmurality assessment capabilities is provided having a malleablesurgical clamp with transmurality capability, and a flexible ablationtool removably insertable within the surgical clamp.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 is a plan view of a surgical clamp in accordance with the presentinvention;

FIG. 2 is a sectional view of an ablation segment of the surgical clampof FIG. 1;

FIG. 3 is a sectional view of an ablation segment including multipleinjection tubes of the surgical clamp of FIG. 1;

FIG. 4 is a sectional view of an ablation segment including orifices ofthe surgical clamp of FIG. 1;

FIG. 5 is a plan view of an alternative embodiment of the surgical clampof FIG. 1;

FIG. 6 is a plan view of the surgical clamp of FIG. 1 including curvedjaws;

FIG. 7 is a sectional view of an ablation segment including insulationsleeve of the surgical clamp of FIG. 1

FIG. 8 is a plan view of the surgical clamp of FIG. 1 includingelongated shafts;

FIG. 9 is a sectional view of the elongated shaft and ablation segmentof the surgical clamp of FIG. 8;

FIG. 10 is a surgical system for operating the surgical clamp inaccordance with the present invention;

FIG. 11 a plan view of an alternative surgical clamp in accordance withthe present invention;

FIG. 12 is a sectional view of an elongated shaft and ablation segmentof the surgical clamp of FIG. 11;

FIGS. 13-17 illustrate additional configurations of a surgical clamp;

FIG. 18 illustrates still another surgical clamp configuration;

FIGS. 19 and 20 illustrate additional details of the jaw elements shownin FIG. 18; and

FIGS. 21 and 22 show additional clamp configurations;

FIG. 23 illustrates a wand-type cryoprobe;

FIG. 24 illustrates an additional surgical clamp adapted to be used inconjunction with the wand-type probe shown in FIG. 23;

FIG. 25 illustrates the probe of FIG. 23 and clamp of FIG. 24 assembledtogether;

FIGS. 26A and 26B illustrate two embodiments of a transmuralityassessment mechanism disposed on a cryoprobe;

FIGS. 27 and 28 illustrate two embodiments of a hinged surgical clamphaving active cryotreatment elements;

FIG. 29 illustrates an additional surgical clamp having a detachablepassive jaw;

FIG. 30 illustrates another surgical clamp having a sliding jaw; and

FIG. 31 shows a pull-wire actuated deflection mechanism used inconjunction with a surgical tool to achieve a clamping effect.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a medical device having a handle assemblyfor actuating a pair of opposing jaw members. The jaw members aremovable relative to one another from a first position, wherein the jawmembers are disposed in a spaced apart relation relative to one another,to a second position, wherein the jaw members cooperate to grasp tissuetherebetween. An ablation tool is connected to at least one of the jawmembers, such that the jaw members are capable of conducting ablationenergy through the tissue grasped therebetween.

Referring now to the figures in which like reference designators referto like elements, there is shown in FIG. 1 a plan view of an exemplaryembodiment of the medical device constructed in accordance with theprinciples of the present invention and designated generally as surgicalclamp 10. The surgical clamp 10 includes a handle assembly havingelongated handles 12 and 14 and may optionally include a lock mechanism16, similar to a conventional surgical hemostat. The elongated handles12, 14 are connected to one another by pivot or hinge 18, and continuedistally in the form of a first elongated jaw 20 and a second elongatedjaw 22. At least one of the elongated jaws 20, 22 includes an ablationtool. For example, the first elongated jaw 20 includes an ablation tool24 positioned on the inner surface 26 of the first elongated jaw 20.

Referring to FIGS. 2-3, the ablation tool 24 includes an ablationsegment 28 having a thermally-transmissive region 30, and defining afluid path having at least one fluid inlet 32 and a fluid outlet 34through the ablation tool 24 to the ablation segment 28, wherein thefluid inlet 32 is in fluid communication with a cryogenic fluid source.Also, even though many materials and structures can be thermallyconductive or thermally transmissive if chilled to a very lowtemperature and/or cold soaked, as used herein, a“thermally-transmissive region” is intended to broadly encompass anystructure or region of the ablation tool 24 that readily conducts heat.

For example, a metal structure exposed (directly or indirectly) to thecryogenic fluid path is considered a thermally-transmissive region 30even if an adjacent polymeric or latex portion also permits heattransfer, but to a much lesser extent than the metal. Thus, thethermally-transmissive region 30 can be viewed as a relative term tocompare the heat transfer characteristics of different catheter regionsor structures, regardless of the material.

Furthermore, while the thermally-transmissive region 30 can include asingle, continuous, and uninterrupted surface or structure, it can alsoinclude multiple, discrete, thermally-transmissive structures thatcollectively define a thermally-transmissive region that is elongate orlinear. Depending on the ability of the cryogenic system, or portionsthereof, to handle given thermal loads, the ablation of an elongatetissue path can be performed in a single or multiple cycle process withor without having to relocate the catheter one or more times or drag itacross tissue.

In an exemplary embodiment, as shown in FIG. 4, the ablation segment 28includes one or more orifices 36, where the orifices 36 define thethermally-transmissive region 30. The orifices 36 enable the applicationof cryogenic fluid directly onto the tissue to be treated.

Additionally, the second elongated jaw 22 can include an ablation tool42 positioned on its inner surface. The ablation tool 42 includes anablation segment 44 having a thermally-transmissive region 46, anddefines a fluid path having at least one fluid inlet 48 and a fluidoutlet 56 through the ablation tool 42 and the ablation segment 46,wherein the fluid inlet 48 is in fluid communication with a cryogenicfluid source.

In an exemplary embodiment, as shown in FIG. 5, the handles 12 and 14are at an acute angle to the first elongated jaw 20 and the secondelongated jaw 22. Furthermore, as shown in FIG. 6, the first elongatedjaw 20 and the second elongated jaw 22 include a curved portion.

Each of FIGS. 1, 5, and 6 illustrate the various inlet (“in”) and outlet(“out”) ports for supplying and evacuating fluid to and from the jaws 20and 22.

Additionally, the first elongated jaw 20 and the second elongated jaw 22are malleable, each have a shape-holding deformability, that is, theyhave rigidity such that the first elongated jaw 20 and the secondelongated jaw 22 each retain a first shape until manipulated to afurther shape with the application of moderate pressure, and untilreshaped. The first elongated jaw 20 and the second elongated jaw 22retain their shape with sufficient rigidity to manipulate the ablationsegment 28 against tissue, and push it past intervening tissue to adesired position.

It is understood that shape, as used herein, is to be construed broadlyto include any contour which is needed to configure the first elongatedjaw 20 and the second elongated jaw 22 for positioning the active ordistal portion of the ablation tool 24, and may include successive bendsor segments having more than one curve, angle, deformation or othernon-linear configuration. The shape-retaining feature of the firstelongated jaw 20 and the second elongated jaw 22 allows an operator tobend the first elongated jaw 20 and the second elongated jaw 22 to ashape or contour, for example around an organ or tissue structure, andhave an optimal configuration for positioning and or orienting theactive or distal region of the first elongated jaw 20 and the secondelongated jaw 22 based upon the particular anatomy of a patient and thelocation of the treatment site.

Further, the stiffness of first elongated jaw 20 and the secondelongated jaw 22 is such that the surgeon can form the first elongatedjaw 20 and the second elongated jaw 22 by hand to a desired shapewithout undue effort, and yet the first elongated jaw 20 and the secondelongated jaw 22 retain the set shape as the surgical clamp 10 ismaneuvered to and held in position at the treatment site. The firstelongated jaw 20 and the second elongated jaw 22 should also besufficiently rigid such that the surgeon can place the ablation segment28 of the ablation tool 24 in pressured contact with the tissuetreatment site. That is, the first elongated jaw 20 and the secondelongated jaw 22 are sufficiently stiff to enable the surgeon to pressthe ablation segment 28 against the tissue to be treated withoutinducing a further deformation in the shape of the first elongated jaw20 and the second elongated jaw 22. The first elongated jaw 20 and thesecond elongated jaw 22 may in some embodiments deflect slightly, andyet have sufficient stiffness to transfer an effective level of lateralforce at their distal end.

In an exemplary embodiment, the first elongated jaw 20 and the secondelongated jaw 22 are configured so that they are deformable in a singleplane, where the first elongated jaw 20 and the second elongated jaw 22remain substantially rigid in all other planes. For example, the firstelongated jaw 20 and the second elongated jaw 22 can be manipulated in afirst plane from a first shape to a second shape, wherein the firstelongated jaw 20 and the second elongated jaw 22 are sufficiently rigidto retain the second shape. The first elongated jaw 20 and the secondelongated jaw 22 also have sufficient rigidity such that the firstelongated jaw 20 and the second elongated jaw 22 cannot be manipulatedin a second plane orthogonal to the first plane, such that the firstelongated jaw 20 and the second elongated jaw 22 are deformable only inthe first plane. As such, the first elongated jaw 20 and the secondelongated jaw 22 are deformable in only one plane.

In accordance with yet another aspect of the invention, as shown in FIG.7, particularly directed to the ablative properties of ablation segments28, 44, the energy distribution during treatment of tissue is furthercontrolled by an adjustable insulation sleeve 52, wherein one eachextends over and partially envelops the ablation segments 28, 44. Aslotted segment in the insulation sleeve 52 forms a partialcircumferential blanket or insulating sleeve which prevents the ablationsegments 28,44 from affecting tissue on one side of the ablationsegments 28, 44, while leaving the other side of the ablation segments28, 44 exposed for contact with tissue.

In a further exemplary embodiment, as shown in FIG. 8, the surgicalclamp 10 includes a shaft assembly having a first shaft 56 and a secondshaft 58 interposed between the handles 12 and 14 and the firstelongated jaw 20 and the second elongated jaw 22. The first shaft 56 anda second shaft 58 operably connect the first elongated jaw 20 and thesecond elongated jaw 22 to the handles 12 and 14 such that the firstelongated jaw 20 and the second elongated jaw 22 are movable relative toone another from a first position, wherein the first elongated jaw 22and the second elongated jaw 20 are disposed in a spaced apart relationrelative to one another, to a second position, wherein the firstelongated jaw 20 and the second elongated jaw 22 cooperate to grasptissue therebetween.

Referring to FIG. 9, the first shaft 56 is substantially hollow,defining a first lumen 60 having at least one input lumen 62 positionedtherein, wherein the first lumen 60 and the at least one lumen 62 definea fluid path to the ablation tool 24 on the first elongated jaw 20. Thefirst lumen 60 and the at least one lumen 62 are in fluid communicationwith the ablation fluid outlet 34 and the ablation fluid inlet 32.

Additionally, similar to the first shaft 56, the second shaft 58 can besubstantially hollow, defining a first lumen having at least one inputlumen positioned therein, wherein the first lumen 60 and the at leastone lumen 62 define a fluid path to the ablation tool 42 on the secondelongated jaw 22. The first lumen and the at least one lumen 62 are influid communication with the ablation fluid outlet 56 and the ablationfluid inlet 48.

The first shaft 56 and the second shaft 58 are malleable, each have ashape-holding deformability, that is, they have a rigidity such that thefirst shaft 56 and the second shaft 58 each retain a first shape untilmanipulated to a further shape with the application of moderatepressure, and until reshaped. The first shaft 56 and the second shaft 58retain their shape with sufficient rigidity to close the first elongatedjaw 20 and the second elongated jaw 22 to grasp the tissue, and push itpast intervening tissue to a desired position.

It is understood that shape, as used herein, is to be construed broadlyto include any contour which is needed to configure the surgical clamp10 for positioning the active or distal portion of the ablation tool 24,and may include successive bends or segments having more than one curve,angle, deformation or other non-linear configuration. Theshape-retaining feature of the first shaft 56 and the second shaft 58allows an operator to bend the first shaft 56 and the second shaft 58 toa shape or contour, for example around an organ or tissue structure, andhave an optimal configuration for positioning and or orienting theactive or distal region of the surgical clamp 10 based upon theparticular anatomy of a patient and the location of the treatment site.

Further, the stiffness of the first shaft 56 and the second shaft 58 issuch that the surgeon can form the first shaft 56 and the second shaft58 by hand to a desired shape without undue effort, and yet the firstshaft 56 and the second shaft 58 retain the set shape as the surgicalclamp 10 is maneuvered to and held in position at the treatment site.The first shaft 56 and the second shaft 58 should also be sufficientlyrigid such that the surgeon can place the ablation segment 28 of theablation tool 24 in pressured contact with the tissue treatment site.That is, the first shaft 56 and the second shaft 58 are sufficientlystiff to enable the surgeon to press the ablation segment 28 against thetissue to be treated without inducing a further deformation in the shapeof the first shaft 56 and the second shaft 58. The first shaft 56 andthe second shaft 58 may in some embodiments deflect slightly, and yethave sufficient stiffness to transfer an effective level of lateralforce at their distal end.

In an embodiment, the first shaft 56 and the second shaft 58 areconfigured so that they are deformable in a single plane, where thefirst shaft 56 and the second shaft 58 remain substantially rigid in allother planes. For example, the first shaft 56 and the second shaft 58can be manipulated in a first plane from a first shape to a secondshape, wherein the first shaft 48 and the second shaft 56 aresufficiently rigid to retain the second shape. The first shaft 56 andthe second shaft 58 also have sufficient rigidity such that the firstshaft 56 and the second shaft 58 cannot be manipulated in a second planeorthogonal to the first plane, such that the first shaft 56 and thesecond shaft 58 are deformable only in the first plane. As such thefirst shaft 56 and the second shaft 58 are deformable in only one plane.

In an exemplary embodiment, as shown in FIG. 10, the present inventionincludes an ablation control system 64. The ablation control system 64includes a supply of cryogenic or cooling fluid 66 in communication withthe surgical clamp 10. A fluid controller 68 is interposed or is in-linebetween the cryogenic fluid supply 66 and the surgical clamp 10 forregulating the flow of cryogenic fluid 66 into the surgical clamp 10 inresponse to a controller command. Controller commands can includeprogrammed instructions, sensor signals, and manual user input. Forexample, the fluid controller 68 can be programmed or configured toincrease and decrease the pressure of the fluid by predeterminedpressure increments over predetermined time intervals.

In another exemplary embodiment, the fluid controller 68 can beresponsive to input from a user input device to permit flow of thecryogenic fluid 66 into the surgical clamp 10. As also shown in FIG. 1,one or more temperature elements 40 in electrical communication with thefluid controller 68 can be provided to regulate or terminate the flow ofcryogenic fluid 66 into the surgical clamp 10 when a predeterminedtemperature at a selected point or points on or within the ablationsegment 28 is/are obtained. For example a temperature element 40 can bepositioned at a point proximate the ablation tool 24 distal end andother temperature elements 40 can be positioned at spaced intervalsbetween the ablation tool 24 distal end and another point that isbetween the distal end and the proximal end.

In another exemplary embodiment, one or more sensor mechanisms, such asa ECG leads, in electrical communication with the controller can beprovided to regulate or terminate the flow of cryogenic fluid 66 intothe ablation tool 24 depending on the electrical activity in the tissuebeing treated. For example, the first elongated jaw 20 and secondelongated jaw 22 may provide feedback that permits a user to gauge thecompleteness of the ablation. Specifically, a lesion blocks electricalsignals because it is non-conductive scar tissue. The first elongatedjaw 20 and second elongated jaw 22 can be used to measure the ability ofthe lesion to block an electrical signal. Referring to FIG. 1, anelectrode 70 is affixed one each to the distal ends of the firstelongated jaw 20 and second elongated jaw 22. In an exemplary use, theelectrodes 70 are used to verify electrical isolation of the lesioncreated by the ablation tool 24. For example, the first elongated jaw 20and the second elongated jaw 22 are opened to position an electrode 70on each side of the lesion. An electrical signal is transmitted from oneelectrode, through the lesion, to the opposite electrode. The lesion isconsidered electrically isolated if the receiving electrode iselectrically silent to the signal.

Alternatively, the electrical sensor mechanisms can be replaced orsupplemented with pressure sensors. The pressure sensors can be used todetermine when the ablation segment is in physical contact with thetissue to be treated.

The cryogenic fluid can be in a liquid or a gas state, or combinationthereof. An extremely low temperature can be achieved within the medicaldevice, and more particularly at the ablation segment by cooling thefluid to a predetermined temperature prior to its introduction into themedical device, by allowing a liquid state cryogenic fluid to boil orvaporize, or by allowing a gas state cryogenic fluid to expand.Exemplary liquids include chlorodifluoromethane, polydimethylsiloxane,ethyl alcohol, HFC's such as AZ-20 (a 50-50 mixture of difluoromethane &pentafluoroethane sold by Allied Signal), and CFC's such as DuPont'sFreon. Exemplary gasses include argon, nitrous oxide, and carbondioxide.

Referring now to FIG. 11, there is shown a plan view of an exemplaryembodiment of a medical device constructed in accordance with theprinciples of the present invention and designated generally as surgicalclamp 100. The surgical clamp 100 includes a shaft assembly havingopposing jaw assemblies 102, 104 with jaw assembly 102 being fixed andjaw assembly 104 being movable between a first position, wherein the jawassemblies 102 and 104 are disposed in a spaced apart relation relativeto one another, to a second position, wherein the jaw assemblies 102 and104 cooperate to grasp tissue therebetween.

The fixed jaw assembly 102 includes a fixed extension shaft 106 and anablation tool 108 disposed on the distal end of the fixed extensionshaft 106, at an acute angle to the fixed extension shaft 106. As shownin FIG. 12, the fixed extension shaft 106 defines a first lumen 110having at least one input lumen 112 positioned therein, wherein thefirst lumen 110 and the at least one input lumen 112 define a fluid pathto the ablation tool 108, wherein the at least one input lumen 112 is influid communication with a cryogenic fluid source. The ablation tool 108includes an ablation segment 114 with a thermally-transmissive region116, defines a fluid path through the ablation tool 108 to the ablationsegment 112, wherein the fluid path is in fluid communication with thefirst lumen 110 and the at least one input lumen 112.

The moveable jaw assembly 104 includes a movable extension shaft 118 anda moveable jaw 120 disposed on the distal end of the moveable extensionshaft 118 at an acute angle to the moveable extension shaft 118. Themoveable extension shaft 118 is operably connected to the fixedextension shaft 106, such that the moveable extension shaft 118 slidesalong the fixed extension shaft 106 to move the moveable jaw 120 betweena first position, wherein the moveable jaw 120 and the ablation tool 108are disposed in a spaced apart relation relative to one another, to asecond position, wherein the moveable jaw 120 and the ablation tool 108cooperate to grasp tissue therebetween.

In an exemplary embodiment, the ablation tool 108 and the moveable jaw120 are malleable, each having a shape-holding deformability, that is,they have rigidity such that the ablation tool 108 and the moveable jaw120 each retain a first shape until manipulated to a further shape withthe application of moderate pressure, and until reshaped. The ablationtool 108 and the moveable jaw 120 retain their shape with sufficientrigidity to manipulate the ablation segment 114 against the tissue, andpush it past intervening tissue to a desired position.

It is understood that shape, as used herein, is to be construed broadlyto include any contour which is needed to configure the ablation tool108 and the moveable jaw 120 for positioning the active or distalportion of the ablation tool 104, and may include successive bends orsegments having more than one curve, angle, deformation or othernon-linear configuration. The shape-retaining feature of the ablationtool 108 and the moveable jaw 120 allows an operator to bend theablation tool 108 and the moveable jaw 120 to a shape or contour, forexample around an organ or tissue structure, and have an optimalconfiguration for positioning and or orienting the active or distalregion of the ablation tool 108 and the moveable jaw 120 based upon theparticular anatomy of a patient and the location of the treatment site.

Further, the stiffness of the ablation tool 108 and the moveable jaw 120is such that the surgeon can form the ablation tool 108 and the moveablejaw 120 by hand to a desired shape without undue effort, and yet theablation tool 108 and the moveable jaw 120 retain the set shape as thesurgical clamp 100 is maneuvered to and held in position at thetreatment site. The ablation tool 108 and the moveable jaw 120 shouldalso be sufficiently rigid such that the surgeon can place the ablationtool 108 and the moveable jaw 120 in pressured contact with the tissuetreatment site. That is, the ablation tool 108 and the moveable jaw 120are sufficiently stiff to enable the surgeon to press the ablationsegment 114 against the tissue to be treated without inducing a furtherdeformation in the shape of the ablation tool 108 and the moveable jaw120. The ablation tool 108 and the moveable jaw 120 may in someembodiments deflect slightly, and yet has sufficient stiffness totransfer an effective level of lateral force at its distal end.

In an exemplary embodiment, the ablation tool 108 and the moveable jaw120 are configured so that they are deformable in a single plane, wherethe ablation tool 108 and the moveable jaw 120 remain substantiallyrigid in all other planes. For example, the ablation tool 108 and themoveable jaw 120 can be manipulated in a first plane from a first shapeto a second shape, wherein the ablation tool 108 and the moveable jaw120 are sufficiently rigid to retain the second shape. The ablation tool108 and the moveable jaw 120 also have sufficient rigidity such that theablation tool 108 and the moveable jaw 120 cannot be manipulated in asecond plane orthogonal to the first plane, such that the ablation tool108 and the moveable jaw 120 are deformable only in the first plane. Assuch the ablation tool 108 and the moveable jaw 120 are deformable inonly one plane.

In an exemplary embodiment, the fixed extension shaft 106 and themoveable extension shaft 118 are malleable, each have a shape-holdingdeformability, that is, they have a rigidity such that the fixedextension shaft 106 and the moveable extension shaft 118 shaft eachretain a first shape until manipulated to a further shape with theapplication of moderate pressure, and until reshaped. The fixedextension shaft 106 and the moveable extension shaft 118 retain theirshape with sufficient rigidity to close the ablation tool 108 and themoveable jaw 120 to grasp the tissue, and push it past interveningtissue to a desired position. The shape-retaining feature of the fixedextension shaft 106 and the moveable extension shaft 118 allows anoperator to bend the fixed extension shaft 106 and the moveableextension shaft 118 to a shape or contour, for example around an organor tissue structure, and have an optimal configuration for positioningand or orienting the active or distal region of the surgical clamp 100based upon the particular anatomy of a patient and the location of thetreatment site.

It is understood that shape, as used herein, is to be construed broadlyto include any contour which is needed to configure the fixed extensionshaft 106 and the moveable extension shaft 118 for positioning theactive or distal portion of the ablation tool 104, and may includesuccessive bends or segments having more than one curve, angle,deformation or other non-linear configuration. The shape-retainingfeature of the fixed extension shaft 106 and the moveable extensionshaft 118 allows an operator to bend the fixed extension shaft 106 andthe moveable extension shaft 118 to a shape or contour, for examplearound an organ or tissue structure, and have an optimal configurationfor positioning and or orienting the active or distal region of thefixed extension shaft 106 and the moveable extension shaft 118 basedupon the particular anatomy of a patient and the location of thetreatment site.

Further, the stiffness of the fixed extension shaft 106 and the moveableextension shaft 118 is such that the surgeon can form the fixedextension shaft 106 and the moveable extension shaft 118 by hand to adesired shape without undue effort, and yet the fixed extension shaftand the moveable extension shaft retains the set shape as the surgicalclamp 100 is maneuvered to and held in position at the treatment site.The fixed extension shaft 106 and the moveable extension shaft 118should also be sufficiently rigid such that the surgeon can place theablation segment of the ablation segment 114 in pressured contact withthe tissue treatment site. That is, the fixed extension shaft 106 andthe moveable extension shaft 118 are sufficiently stiff to enable thesurgeon to press the ablation segment 114 against the tissue to betreated without inducing a further deformation in the shape of the fixedextension shaft 106 and the moveable extension shaft 118. The fixedextension shaft 106 and the moveable extension shaft 118 may in someembodiments deflect slightly, and yet haves sufficient stiffness totransfer an effective level of lateral force at its distal end.

In an embodiment, the fixed extension shaft 106 and the moveableextension shaft 118 are configured so that they are deformable in asingle plane, where the fixed extension shaft 106 and the moveableextension shaft 118 remain substantially rigid in all other planes. Forexample, the fixed extension shaft 106 and the moveable extension shaft118 can be manipulated in a first plane from a first shape to a secondshape, wherein the fixed extension shaft 106 and the moveable extensionshaft 118 are sufficiently rigid to retain the second shape. The fixedextension shaft 106 and the moveable extension shaft 118 also havesufficient rigidity such that the fixed extension shaft 106 and themoveable extension shaft 118 cannot be manipulated in a second planeorthogonal to the first plane, such that the fixed extension shaft 106and the moveable extension shaft 118 are deformable only in the firstplane. As such the fixed extension shaft 106 and the moveable extensionshaft 118 are deformable in only one plane.

Referring to FIG. 12, the moveable extension shaft 118 defines a firstlumen 122 having at least one input lumen 124 positioned therein, thefirst lumen 122 and the at least one input lumen 124 defining a fluidpath to the moveable jaw 120, wherein the at least one fluid input lumen124 is in fluid communication with a cryogenic fluid source. Themoveable jaw 120 is an ablation tool including an ablation segment 126with a thermally-transmissive region 128, and defining a fluid paththrough the moveable jaw 120 to the ablation segment 126, wherein thefluid path is in fluid communication with the first lumen 122 and the atleast one input lumen 124.

The fixed jaw assembly 102 and the moveable jaw 104 assembly areoperably connected to a handle assembly 103. The handle assembly 103includes a fixed handle 132 attached to the fixed extension shaft 106and a lever arm 134 pivotally connected to the fixed handle 132. Thelever arm 134 is attached to the movable extension shaft, 118 such thatas the lever arm 134 pivots about the fixed handle 132 from a startposition, the moveable jaw 120 moves from a first position to a secondposition.

Referring now to FIG. 13, there is shown a plan view of an exemplaryembodiment of a medical device constructed in accordance with theprinciples of the present invention and designated generally as surgicalclamp 200. The surgical clamp 200 includes a jaw assembly having a firstjaw 202, and a second jaw 204 in opposing relation. The first jaw 202and the second jaw 204 are movable between a first position, wherein thefirst jaw 202 and the second jaw 204 are disposed in a spaced apartrelation relative to one another, to a second position, wherein thefirst jaw 202 and the second jaw 204 cooperate to grasp tissuetherebetween. The first jaw 202 and the second jaw 204 are connected toan elongated shaft assembly 206, wherein a handle assembly 208 isconnected to the elongated shaft assembly 206 opposite the first jaw 202and the second jaw 204. At least one of the first jaw 202 and the secondjaw 204 includes an ablation tool. For example, the first jaw 202includes an ablation tool 210 positioned on the inner surface 212 of thefirst jaw 202.

The elongated shaft assembly 206 defines a first lumen having at leastone input lumen positioned therein (not shown). The first lumen and theat least one input lumen define a fluid path to the ablation tool 210,wherein the at least one input lumen is in fluid communication with acryogenic fluid source. The ablation tool 210 includes an ablationsegment with a thermally-transmissive region, and defines a fluid paththrough the ablation tool to the ablation segment, wherein the fluidpath is in fluid communication with the first lumen and the at least oneinput lumen.

Additionally, the second jaw 204 can include an ablation tool 220 havingan ablation segment with a thermally-transmissive region similar to thatof ablation tool 210 disposed on first jaw 202.

In an exemplary embodiment, the first jaw 202 and the second jaw 204 aremalleable, each have a shape-holding deformability, that is, they haverigidity such that the first jaw 202 and the second jaw 204 each retaina first shape until manipulated to a further shape with the applicationof moderate pressure, and until reshaped. The first jaw 202 and thesecond jaw 204 retain their shape with sufficient rigidity to manipulatethe ablation segment 210 against tissue, and push it past interveningtissue to a desired position.

It is understood that shape, as used herein, is to be construed broadlyto include any contour which is needed to configure the first jaw 202and the second jaw 204 for positioning the active or distal portion ofthe ablation tool, and may include successive bends or segments havingmore than one curve, angle, deformation or other non-linearconfiguration. The shape-retaining feature of the first jaw 202 and thesecond jaw 204 allows an operator to bend the first jaw 202 and thesecond jaw 204 to a shape or contour, for example around an organ ortissue structure, and have an optimal configuration for positioning andor orienting the active or distal region of the first jaw 202 and thesecond jaw 204 based upon the particular anatomy of a patient and thelocation of the treatment site.

Further, the stiffness of the first jaw 202 and the second jaw 204 issuch that the surgeon can form the first jaw 202 and the second jaw 204by hand to a desired shape without undue effort, and yet the first jaw202 and the second jaw 204 retain the set shape as the surgical clamp200 is maneuvered to and held in position at the treatment site. Thefirst jaw 202 and the second jaw 204 should also be sufficiently rigidsuch that the surgeon can place the ablation segment of the ablationtool in pressured contact with the tissue treatment site. That is, thefirst jaw 202 and the second jaw 204 are sufficiently stiff to enablethe surgeon to press the ablation segment against the tissue to betreated without inducing a further deformation in the shape of the firstjaw 202 and the second jaw 204. The first jaw 202 and the second jaw 204may in some embodiments deflect slightly, and yet have sufficientstiffness to transfer an effective level of lateral force at its distalend.

In an exemplary embodiment, the first jaw 202 and the second jaw 204 areconfigured so that they are deformable in a single plane, where thefirst jaw 202 and the second jaw 204 remain substantially rigid in allother planes. For example, the first jaw 202 and the second jaw 204 canbe manipulated in a first plane from a first shape to a second shape,wherein the first jaw 202 and the second jaw 204 are sufficiently rigidto retain the second shape. The first jaw 202 and the second jaw 204also have sufficient rigidity such that the first jaw 202 and the secondjaw 204 cannot be manipulated in a second plane orthogonal to the firstplane, such that the first jaw 202 and the second jaw 204 are deformableonly in the first plane. As such the first jaw 202 and the second jaw204 are deformable in only one plane.

In an exemplary embodiment, the elongated shaft assembly 206 ismalleable, having a shape-holding deformability, that is, it hasrigidity such that the elongated shaft assembly 206 retains a firstshape until manipulated to a further shape with the application ofmoderate pressure, and until reshaped. The elongated shaft assembly 206retains its shape with sufficient rigidity to close the first jaw 202and the second jaw 204 to grasp the tissue, and push it past interveningtissue to a desired position.

It is understood that shape, as used herein, is to be construed broadlyto include any contour which is needed to configure the surgical clamp200 for positioning the active or distal portion of the ablation tool,and may include successive bends or segments having more than one curve,angle, deformation or other non-linear configuration. Theshape-retaining feature of the elongated shaft assembly 206 allows anoperator to bend the elongated shaft assembly 206 to a shape or contour,for example around an organ or tissue structure, and have an optimalconfiguration for positioning and or orienting the active or distalregion of the surgical clamp 200 based upon the particular anatomy of apatient and the location of the treatment site.

Further, the stiffness of the elongated shaft assembly 206 is such thatthe surgeon can form the elongated shaft assembly 206 by hand to adesired shape without undue effort, and yet the elongated shaft assembly206 retains the set shape as the surgical clamp 200 is maneuvered to andheld in position at the treatment site. The elongated shaft assembly 206should also be sufficiently rigid such that the surgeon can place theablation segment of the ablation tool in pressured contact with thetissue treatment site. That is, the elongated shaft assembly 206 issufficiently stiff to enable the surgeon to press the ablation segmentagainst the tissue to be treated without inducing a further deformationin the shape of the elongated shaft assembly 206. The elongated shaftassembly 206 may in some embodiments deflect slightly, and yet hassufficient stiffness to transfer an effective level of lateral force atits distal end.

In an embodiment, the elongated shaft assembly 206 is configured so thatit is deformable in a single plane, where the elongated shaft assembly206 remains substantially rigid in all other planes. For example, theelongated shaft assembly 206 can be manipulated in a first plane from afirst shape to a second shape, wherein the elongated shaft assembly 206is sufficiently rigid to retain the second shape. The elongated shaftassembly 206 also has sufficient rigidity such that the elongated shaftassembly 206 cannot be manipulated in a second plane orthogonal to thefirst plane, such that the elongated shaft assembly 206 is deformableonly in the first plane. As such the elongated shaft assembly 206 aredeformable in only one plane.

Referring now to FIG. 14, an exemplary tool is shown having a handleportion 208 from which extends a probe 211 having a cooling segment 212.As with all disclosed embodiments, the cooling segment 212 can beprovided with a smooth or textured tissue engaging surface 214. In FIG.14, the tissue-engaging surface 214 is textured to have “teeth.” Asecond element 216 is movable relative to the probe to define a tissuecapture zone 218. A distal region 220 of the second element 216 can havea complementary shape to the cooling segment 212 and be smooth (asshown) or textured. As the probe 211 and the second element 216 aremoved axially with respect to each other, the tissue capture zone 218increases or decreases in size. In the illustrated embodiment, thesecond element 216 is secured to the probe 211 and is axially slidablewith respect thereto by axially moving a proximal portion 222 of thesecond element 216.

With respect to FIG. 15, a different actuating mechanism is shown in anexemplary tool having a handle portion 224 from which extends a probe226 having a cooling segment 228. A second element 230 is movablerelative to the probe 226 to define a tissue capture zone 232. As theprobe 226 and the second element 230 are moved axially with respect toeach other, the tissue capture zone 232 increases or decreases in size.In the illustrated embodiment, the second element 230 is secured to theprobe 226 and is axially slidable with respect thereto by axially movinga proximal portion 234 of the second element by pulling a handle, lever,or trigger 236 that is engaged with the proximal portion of the secondelement. A spring 238 or other bias means can be provided to either urgethe second element 230 in either the distal or proximal direction.

FIG. 16 shows yet another configuration wherein a cooling element 240 isjuxtaposed with a second element 242 and wherein the elements are biasedapart. A sleeve or handle element 244 is slidable with respect to theelements so that as it is moved distally it urges the elements together.

Referring to FIG. 17 another clamping tool is disclosed that includes ahandle portion 246 having an actuator 248 that pivots or rotates foreand aft. The actuator 248 is coupled to a pull or push wire 250 that issecured to a distal portion of an elongate shaft structure 252 to causethe shaft structure to clamp tissue 254. As shown, the shaft structure252 includes an insulating distal portion 256, a bellows or coil portion258 that provides a clamping effect, and a cooling segment 260. Acoolant injection tube 262 introduces coolant into the cooling segment260. The elongate shaft structure 252 can be transitioned from asubstantially linear configuration to the configuration shown or it canbe preformed to substantially the configuration shown and actuated totighten the space between the insulating distal portion 256 and thecooling segment 260 which can further be insulated on its outward face.As shown, the wire 250 is secured at its distal end to a shim 264.

FIG. 18 illustrates yet another configuration of a tool including ahandle 266, actuator 268, insulated shaft 270, first jaw 272, and secondjaw 274, wherein manipulation of the actuator 268 causes the jaws toopen and close or move relative to each other. The figure depicts thejaws in both the open and clamped state. Coolant can flow to and/orthrough one or both jaws and both jaws can be insulated except at thepoint where they meet. One or both jaws can be provided with temperatureand/or impedance measurement devices to monitor and evaluate lesionformation and characteristics. In an embodiment a temperature sensor isassociated with a jaw that does not have a cooling element. The jaws areclamped together with tissue therebetween. The transmurality of a lesioncould be ascertained when the temperature sensor detects a temperatureof 40 degrees Centigrade for two minutes. Of course time and temperaturemay be different for different types, conditions and thickness oftissue.

FIGS. 19 and 20 show additional details of the first jaw 272 and thesecond jaw 274, respectively; wherein the first jaw made of aninsulating material defines a recess 276 shaped to receive an elongatecooling element 278 affixed to insulating material. The cooling element278 may be removable from the jaw elements. The cooling element 278maybe inserted and retained in place on one of the jaws. An ablation oftissue may be performed by placing the jaws of the medical device aroundthe tissue and activating an ablation element. Upon completion of theablation, the cooling element may be removed from the jaw and themedical device may be used as a “wand-like” device to perform additionalprocedures.

In an alternate embodiment, one of the two jaws can be removable so thata single jaw with an active element, for example the ablation or coolingelement, is provided. Thus, the device can be convertible from aclamping tool to a “wand” type device for use in procedures notrequiring clamping.

FIG. 21 illustrates yet another configuration for the clamping device.Here, cooling segment 260 can be deflected from its normal position to avariety of deflection positions via use of actuator 248 (not shown).Cooling segment 260 may be deflected to an angle of choice bymanipulation of the actuator. Coolant can then be introduced to coolingsegment 260 via the internal injection tube (not shown).

FIG. 22 illustrates yet another configuration for a clamping devicewherein a cooling element 280 is sidably disposed within an insulatingsheath 282. The distal portion of the cooling element 281 and the distalportion of the sheath 283 are angled with respect to their proximalportion so that extension and retraction of the cooling element withrespect to the sheath opens and closes a tissue-clamping zone 284.

Although generally shown as a cryogenic ablation tool, it is understoodthat in other embodiments the ablation segment applies other types ofenergy or combination of energies, to the tissue to be treated,including, but not limited to, cryogenic energy, radio frequency (RF)energy, microwave energy, ultrasound energy, laser energy, and contactheating energy. It is further understood that other devices can becoupled to the guide distal end, for example, cameras, video devices,probes and other components can be affixed to the guide for variousapplications. For example, pacing/sensing electrodes can be affixed topoints on the slotted segment.

The medical device of the present invention is well suited for treatingtissue in a variety of locations in the body during invasive surgicalprocedures. Illustrative applications include open thoracic andperitoneal surgery as well as endoscopic procedures, e.g., treatingtissue located at or near the heart, intestines, uterus, and otherregions for which surgical or endoscope assisted surgical access andtopical tissue treatment, or cauterization or ablation is appropriate,as well as ophthalmic surgery, and tumor ablation and variousapplications preparatory to further surgical steps.

FIG. 23 illustrates a wand-type cryoprobe. The probe 300 includes ahandle portion 301 and a manually deformable main shaft 302. The shaft302 includes a malleable and deformable distal section 303, having abellows-shaped configuration that may be made of convoluted stainlesssteel tubing. At the very distal tip of the distal section 303 is a tipextension 305 for use with suture during surgical procedures. The tipextension 305 may include a hollow section and a solid section. Thesolid section the tip extension 305 may have a drilled hole or eyeletwith a small diameter of, for example, 0.05 to 0.09 inch, which isadapted for receiving a wire or other suitable device (not shown); andprovides the operator or physician the capability of grasping andmanipulating the probe around the target tissue. The edges of this holeor eyelet are rounded in order to prevent severing the wire or othersuitable device.

The probe 300 further includes a slidable insulation sheath 310 disposedover the central portion of the main shaft 302, adapted to slide alongthe direction of the arrows F and R as shown in the figure. The sheath310 can slide over varying lengths of the distal section 303, to coverup portions of the distal section and thereby insulate said portionsfrom heat transfer.

Coolant enters the probe through a central injection tube 315, whichextends to the distal tip 305 and includes at least one exit point (forexample, at least one nozzle) proximate the distal tip 305. Atemperature sensor mechanism 318 is included proximate the exit point ofthe injection tube 315 to measure the temperature of fluid exiting thetube, and to render a measure of the overall temperature around the tipof the probe 300. In this exemplary embodiment, the injection tube 315runs concentrically within an outer tube (not numbered) thereby forminga return space surrounding the injection tube 315 and extending back tothe fluid connector 322. A heat exchanger 320 is also included along theinjection tubing as shown, inside the shaft 302. The heat exchanger 320includes a portion of the injection tubing 315 and a small diameterthermally conductive wire 321, for example solid copper, which is coiledor wound around the portion of injection tubing 315. After the coolingfluid is provided to the thermally-transmissive region of the distal tip305, and injected into the tip, the spent vapor is returned through thereturn space where it flows over the heat exchanger to subcool thecooling fluid in the portion of the injection tubing 315. Subcooling ofthe cooling fluid may prevent the formation of gas bubbles in thecooling fluid prior to injection into the distal tip 305. The handleportion includes a quick-connecting high-pressure line and port 322 toprovide a means of supplying and evacuating refrigerant from the device.An alternate temperature reading connector 325 is also provided forconnection with a plug disposed on the surgical clamp disclosed in FIG.24 below.

FIG. 24 illustrates a surgical clamp 400 adapted to be used inconjunction with the wand-type probe 300 shown in FIG. 23. Clamp 400includes a handle portion 401 and a main shaft 402. Handle portion 401includes a handle housing 404 that encloses a trigger extension spring405, with a handle pin 406 at the proximal end of spring 405. Trigger407 is pivotally coupled to handle 401. Trigger lock 408 and trigger pin409 act to prevent the unintentional activation of the trigger.

Main shaft 402 extends from handle portion 401 and is covered by aprotective sleeve 403. Main shaft 402 includes a tightly-wound main coil410 and a proximal jaw 411 from which extend a pair of thermocouplesensors 412. Main coil 410 provides flexibility and malleability to mainshaft 402. The distal sensor includes a distal reinforcement element 413and a distal jaw 414. The proximal sensor includes a proximalreinforcement element 415.

A mobile spring 416 provides the linkage between handle portion 401 andmain shaft 402. Mobile spring 416 is enclosed by protective sleeve 417.Linkage 418 provides the mechanical interface between the trigger 407and main shaft 402 in addition to thermocouple wire 419 coupled tospring attachment 420. An alternate temperature reading miniature plug421 is also included in order to measure the average temperature of theablation site and the temperature opposite the ablation site. Plug 421is used in conjunction with an alternate temperature recording device toprovide accurate readings from each temperature sensor 412. Plug 421 andassociated switching circuitry enables one temperature sensor whiledisabling the other thereby guaranteeing the recording from only onetemperature sensor at a time.

FIG. 25 illustrates the probe 300 of FIG. 23 assembled together with theclamp 400 of FIG. 24. Sensors 412 are used for transmurality assessmentof lesions by measuring the temperature and/or impedence of the tissuebetween the jaws of the clamp. Two illustrative examples of a sensorused in connection with the present invention are shown in FIGS. 26A and26B.

FIGS. 26A and 26B illustrate two embodiments of a transmuralityassessment mechanism disposed on an ablation device such as a cryoprobeor surgical clamp. Typically, one or more sensor mechanisms, having oneor more sensor electrodes 422, may be disposed on one or more jaws 423of the ablation device. Sensor electrodes 422 can measure temperature ofthe opposing jaw and/or impedence of the tissue being treated betweenopposing jaws of the ablation device. The resulting temperature orimpedence readings provide an indication of the transmurality of thelesion. Alternatively, the impedance sensor electrodes 422 may bedisposed on one jaw or both jaws to measure the existence of iceformation in the tissue or the propagation of ice in the tissue.

FIG. 27 illustrates one embodiment of the surgical clamp of the presentinvention. The embodiment of FIG. 27 represents a hinged surgical clamphaving active cryotreatment elements. Probe 427 includes two jaws, apassive, mobile jaw 424 and a stationary, active jaw 428. Passive jaw424 is mobile and is controlled by a pull wire actuation mechanism 425.Mechanism 425 controls the rotation of jaw 424 about hinge 426. Pullwire actuation mechanism 425 is covered by protective insulation sleeve429. FIG. 27 provides an illustration of one type of jaw arrangement fora cryoprobe that provides controlled rotary movement of the jaws inorder to properly position the cryoprobe at the target tissue.

FIG. 28 illustrates an alternate embodiment of a hinged surgical clamphaving active cryotreatment elements. In this embodiment, passive jaw424 is of a different shape and size than the jaw depicted in FIG. 27.Passive jaw 424 includes sensing elements and can rotate about hinge 426and is again controlled by a pull wire actuation mechanism 425 withinsleeve 429. Actuation mechanism 425 may include a force limiting springor latch that creates a space between passive jaw 424 and active jaw 428to prevent the user from over-squeezing actuation mechanism 425.Actuation mechanism 425 may be coupled to a device that controls themovement of passive jaw 425 such as an on/off switch, a joystick, or oneor more motors controlled by a remote control unit.

FIG. 29 illustrates another embodiment of a surgical clamp having adetachable passive jaw. Passive jaw 424 includes temperature sensingelements for transmurality assessment. Jaw 424 is also removable and canbe detached from the probe. Active jaw 428 is supported by a removablestiffening member 430, which provides rigidity. A safety gap 431 isformed between jaw 424 and jaw 428 in order to prevent over-squeezing ofactuation mechanism 425.

FIG. 30 illustrates yet another embodiment of the surgical clamp of thepresent invention. The clamp depicted in FIG. 30 includes a mobile,passive jaw 432 that slides along a flexible shaft 433 while active jaw434 remains fixed. Mobile jaw 432 can be spring loaded and controlledvia an actuation member 435 and an on/off switch 437. Mobile jaw 432 canbe controlled to slide along shaft 433 relative to fixed active jaw 434in order to increase or decrease the clamping gap 436 between theopposing jaws. Mobile jaw 432 includes one or more thermocouples, eitherseparated or along one common support, to provide transmuralityfeedback. All of the external members are removable and the active jawmay be used as a linear ablation device.

FIG. 31 illustrates still another embodiment of the present inventionthat includes a pull-wire actuated deflection mechanism used inconjunction with a surgical tool to achieve a clamping effect. In thisembodiment, two pull-wires 438 and 440 provide a non-symmetricbi-directional clamping mechanism. The pull-wires can be manipulated todeflect jaw 439 in a particular direction. Jaw 439 folds downward andclamps down around the target tissue.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. In addition, unless mention was made above to thecontrary, it should be noted that all of the accompanying drawings arenot to scale. A variety of modifications and variations are possible inlight of the above teachings without departing from the scope and spiritof the invention, which is limited only by the following claims.

1. A method for treating a tissue region, comprising the steps of:providing a clamp defining a first handle portion, a first shaftextending from the first handle portion, a proximal jaw coupled to theshaft, a distal jaw coupled to the shaft, and a trigger mechanismcoupled to the first handle portion and at least one of the proximal anddistal jaws, wherein activation of the trigger mechanism causes at leastone of the proximal and distal jaws to move; providing an instrumentdefining a second handle portion and a cryotreatment element coupled tothe second handle portion; coupling the first handle portion to thesecond handle portion; positioning the cryotreatment element proximateto at least one of the proximal and distal jaws; and thermally affectingthe tissue region with the cryotreatment element.
 2. The methodaccording to claim 1, further comprising the step of activating thetrigger mechanism to place a portion of the tissue region between theproximal and distal jaws.
 3. The method according to claim 1, whereinthe step of thermally affecting the tissue region includes circulating acryogenic fluid through the cryotreatment element.
 4. The methodaccording to claim 1, further comprising the step of measuring atemperature of the tissue region.
 5. The method according to claim 1,further comprising the step of measuring an electrical activityproximate the tissue region.
 6. The method according to claim 1, furthercomprising the step of assessing a transmurality property of the tissueregion.
 7. The method according to claim 6, wherein the step ofassessing a transmurality property includes measuring an impedance ofthe tissue region.
 8. The method according to claim 1, furthercomprising the step of bending at least a portion of the first shaft. 9.The method according to claim 1, further comprising the step of bendingat least a portion of the cryotreatment element.